Intraperitoneal Techniques of Local Anaesthesia During Laparoscopic Cholecystectomy

NCT ID: NCT01090882

Last Updated: 2024-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2009-10-31

Brief Summary

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Pain following laparoscopic cholecystectomy (LC) results in morbidity and is a barrier to same day discharge. In several trials local anaesthetic (LA) washed over the liver and gall bladder decreases pain. In many patients pain has a strong component attributable to diaphragmatic origin. A wash of LA over the liver and gall bladder is unlikely to provide high levels of analgesia to pain fibres from the diaphragm. The investigators hypothesise that LA injected to the right hemidiaphragm during LC would be more effective than wash.

Methods Double blind randomised controlled trial of 128 consecutive subjects undergoing elective LC. Control -sham injection of diaphragm and sham wash over liver/GB with saline; Test treatment 'subperitoneal LA' - bupivocaine injection/sham wash; Internal control 'topical LA' - sham injection/bupivocaine wash. Primary outcome: pain scores in theatre recovery and the ward. Secondary outcomes: analgesic use, physiological observations, time to eating and mobilising, day case surgery.

Detailed Description

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Conditions

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Gall Stones

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

Sham wash, sham injection

Group Type SHAM_COMPARATOR

0.9% normal saline solution

Intervention Type DRUG

20ml 0.9% NaCl

Subperitoneal injection

Local anaesthetic injection to diaphragm with sham wash over liver and gall bladder

Group Type EXPERIMENTAL

Bupivocaine

Intervention Type DRUG

20ml 0.25% at beginning of operation

Topical LA

Local anaesthetic washed over gall bladder and liver. Sham injection of diaphragm

Group Type ACTIVE_COMPARATOR

Bupivocaine

Intervention Type DRUG

20ml 0.25% at beginning of operation

Interventions

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Bupivocaine

20ml 0.25% at beginning of operation

Intervention Type DRUG

0.9% normal saline solution

20ml 0.9% NaCl

Intervention Type DRUG

Other Intervention Names

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marcaine marcaine

Eligibility Criteria

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Inclusion Criteria

* Elective laparoscopic cholecystectomy
* 18 years old or over

Exclusion Criteria

* Emergency surgery
* Under 18 year olds
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospitals Coventry and Warwickshire NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Keith J Roberts, MRCS

Role: PRINCIPAL_INVESTIGATOR

University Hospital Coventry and Warwickshire NHS Trust

Locations

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UHCW NHS Trust

Coventry, Warwickshire, United Kingdom

Site Status

Countries

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United Kingdom

References

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Roberts KJ, Gilmour J, Pande R, Nightingale P, Tan LC, Khan S. Efficacy of intraperitoneal local anaesthetic techniques during laparoscopic cholecystectomy. Surg Endosc. 2011 Nov;25(11):3698-705. doi: 10.1007/s00464-011-1757-3. Epub 2011 Jun 3.

Reference Type DERIVED
PMID: 21638181 (View on PubMed)

Other Identifiers

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UHCW 1

Identifier Type: -

Identifier Source: org_study_id

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